TEST_013 The data that users send and receive follows the FHIR healthcare interoperability standard
Test type​
System compatibility
Linked activities​
- MDS-449
Result​
- Passed
- Failed
Description​
Test carried out at the user interface level, to verify that the data exchanged between users and the device adheres to the FHIR (Fast Healthcare Interoperability Resources) standard. The objective of this test is to ensure that all patient images and associated information, as well as preliminary reports generated by the device, are formatted and transmitted in compliance with the FHIR standard, validating the device's ability to seamlessly integrate with other healthcare systems and electronic health records. By confirming this, we guarantee that the device can efficiently exchange crucial patient data with other medical tools and systems, promoting data consistency and facilitating secure and standardized, structured data sharing and interoperability within the broader healthcare ecosystem.
Test checklist​
The following checklist verifies the completion of the goals and metrics specified in the requirement REQ_006
Requirement verification​
- Users understand how to send data
- Users understand how data is received
Evidence​
For compliance with the FHIR standard, the most basic body request that a user can send to the API must have the following structure:
{
"resourceType": "CommunicationRequest",
"identifier": {
"system": "The namespace for the identifier value",
"value": "The value that is unique",
},
"subject": {
"reference": "patient/id",
},
"payload": [
{"attachment": {"contentType": "image/jpeg", "data": "base64 image 1"}},
{"attachment": {"contentType": "image/png", "data": "base64 image 2"}},
],
}
This JSON is in compliance with the FHIR healthcare interoperability standard due to the following reasons:
"resourceType": "CommunicationRequest": This field indicates that the resource being represented is aCommunicationRequest, which is in accordance with the FHIR standard. In FHIR, each resource type must have a "resourceType" field specifying its type."identifier": This field represents an identifier for theCommunicationRequest. In FHIR, resources can have identifiers to uniquely distinguish them. It includes a "system" (the namespace for the identifier value) and a "value" (the unique identifier value). This structure adheres to the FHIR standard for identifiers."subject": The "subject" field indicates the subject of theCommunicationRequest, and it uses a "reference" to a patient resource with the ID "patient/id." In FHIR, references are used to link resources together, and this reference to a patient resource is compliant with the standard."payload": The "payload" field is used to specify the content of theCommunicationRequest. It includes an array ofAttachment(a FHIR general-purpose datatype), each describing a payload item. Each payload item has a "contentType" (indicating the type of content, in this case, images) and a "data" field containing the actual content in base64-encoded format. This structure conforms to the FHIR standard for specifying payload content in aCommunicationRequest.
As for the response received by the user, due to the complexity and particularities of the report issued by the device, we have not been able to perfectly adhere to the FHIR DiagnosticReport resource (https://www.hl7.org/fhir/diagnosticreport.html). However, leveraging the flexibility offered by this standard to extend and adapt it, we have tailored it to our needs and have added some sections and replaced some field names with others that fall closer to our domain.
Thus, the JSON issued by the device for the diagnosis support functionality is structured as follows:
{
"coding": [
{
"code": "250171008",
"display": "Clinical history and observation finding",
"system": "http://snomed.info/sct"
},
{
"code": "10206-1",
"display": "Physical findings of Skin Narrative",
"system": "http://loinc.org/"
}
],
"device": {
"resourceType": "Device",
"name": "Legit.Health Plus",
"manufacturer": "AI LABS GROUP SL",
"coding": {
"code": "legit.health.plus.custom",
"display": "Dermatology picture archiving and communication system application software",
"system": "http://snomed.info/sct"
}
},
"conclusions": [
{
"coding": {
"code": "ND56.0",
"system": "ICD-11"
},
"name": "Hematoma",
"probability": 99.51
},
{
"coding": {
"code": "",
"system": "ICD-11"
},
"name": "Non-specific lesion",
"probability": 45.49
},
{
"coding": {
"code": "2A21.10, XH8VS0",
"system": "ICD-11"
},
"name": "Urticaria pigmentosa",
"probability": 2.09
},
{
"coding": {
"code": "EF20.1, XH4KP7",
"system": "ICD-11"
},
"name": "Angiokeratoma",
"probability": 1.93
},
{
"coding": {
"code": "EH94",
"system": "ICD-11"
},
"name": "Scar",
"probability": 1.89
}
],
"explainabilityMedia": {
"modality": [
"Clinical",
"Dermatoscopic"
],
"resourceType": "Media",
"type": "Image"
},
"mediaValidity": {
"metrics": {
"quality": {
"valid": true,
"score": 59.0,
"category": "Acceptable"
},
"domain": {
"valid": false,
"score": 49.96,
"category": "Non dermatological"
}
},
"isValid": false
},
"metrics": {
"category": "Calculation",
"resourceType": "DeviceMetric",
"sensitivity": 85.34,
"specificity": 99.58
},
"preliminaryFindings": {
"hasConditionSuspicion": 99.99,
"needsSpecialistAttention": 99.71,
"isMalignantSuspicion": 0.0,
"isPreMalignantSuspicion": 0.0
},
"imagingStudySeries": [
{
"conclusions": [
{
"coding": {
"code": "",
"system": "ICD-11"
},
"name": "Non-specific lesion",
"probability": 45.49
},
{
"coding": {
"code": "2A21.10, XH8VS0",
"system": "ICD-11"
},
"name": "Urticaria pigmentosa",
"probability": 2.09
},
{
"coding": {
"code": "EF20.1, XH4KP7",
"system": "ICD-11"
},
"name": "Angiokeratoma",
"probability": 1.93
},
{
"coding": {
"code": "XH5AW4",
"system": "ICD-11"
},
"name": "Haemangioma",
"probability": 1.92
},
{
"coding": {
"code": "EH94",
"system": "ICD-11"
},
"name": "Scar",
"probability": 1.89
}
],
"explainabilityMedia": {
"modality": "Clinical",
"resourceType": "Media",
"type": "Image"
},
"mediaValidity": {
"metrics": {
"quality": {
"valid": true,
"score": 66.0,
"category": "Acceptable"
},
"domain": {
"valid": false,
"score": 0.0,
"category": "Non dermatological"
}
},
"isValid": false
},
"metrics": {
"category": "Calculation",
"resourceType": "DeviceMetric",
"sensitivity": 84.11,
"specificity": 99.28
},
"preliminaryFindings": {
"hasConditionSuspicion": 99.99,
"needsSpecialistAttention": 99.42,
"isMalignantSuspicion": 0.0,
"isPreMalignantSuspicion": 0.0
}
},
{
"conclusions": [
{
"coding": {
"code": "ND56.0",
"system": "ICD-11"
},
"name": "Hematoma",
"probability": 99.51
},
{
"coding": {
"code": "XH5AW4",
"system": "ICD-11"
},
"name": "Angioma",
"probability": 0.09
},
{
"coding": {
"code": "XH5AW4",
"system": "ICD-11"
},
"name": "Haemangioma",
"probability": 0.07
},
{
"coding": {
"code": "LA90.2, LC51, XH23S6",
"system": "ICD-11"
},
"name": "Venous malformation",
"probability": 0.02
},
{
"coding": {
"code": "EF40",
"system": "ICD-11"
},
"name": "Purpura",
"probability": 0.02
}
],
"explainabilityMedia": {
"modality": "Dermatoscopic",
"resourceType": "Media",
"type": "Image"
},
"mediaValidity": {
"metrics": {
"quality": {
"valid": true,
"score": 52.0,
"category": "Acceptable"
},
"domain": {
"valid": true,
"score": 99.92,
"category": "Dermatological"
}
},
"isValid": true
},
"metrics": {
"category": "Calculation",
"resourceType": "DeviceMetric",
"sensitivity": 84.9,
"specificity": 99.34
},
"preliminaryFindings": {
"hasConditionSuspicion": 100.0,
"needsSpecialistAttention": 100.0,
"isMalignantSuspicion": 0.0,
"isPreMalignantSuspicion": 0.0
}
}
],
"resourcetype": "DiagnosticReport",
"status": "Preliminary",
"analysisDuration": "0.7502 secs"
}
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Tester: JD-017, JD-009, JD-004
- Approver: JD-005